MAUDE Adverse Event Report: NATUS MEDICAL INCORPORATED RETCAM ENVISION, SYSTEM WITH FA

Model Number	61-000300
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial report ref to natus complaint (b)(4).Per 18-000623 retcam envision risk analysis, hazard id - 6.9, the risk is considered moderate.Install date: 19-may-2022.Further investigation to be carried out on the affected part.
Event or Problem Description
Retcam envision, system with fa - customer reported the monitor is sagging and stated that there was potential for injury, as the monitor first fell during image acquisition.Another member of staff in the or was able to stabilize it at that time.Customer confirmed that the issue was resolved however, it took about 2.5 full revolutions of the adjustment screw to hold the monitor up.
Event or Problem Description
Retcam envision, system with fa - customer reported the monitor is sagging and stated that there was potential for injury, as the monitor first fell during image acquisition.Another member of staff in the or was able to stabilize it at that time.Customer confirmed that the issue was resolved however, it took about 2.5 full revolutions of the adjustment screw to hold the monitor up.
Additional Manufacturer Narrative
Follow up report 001 ref to natus complaint#(b)(4).Instructions were provided to the customer on how to adjust the monitor arm.Customer confirmed that the issue was resolved however, it took about 2.5 full revolutions of the adjustment screw to hold the monitor up.Customer was informed that oil/grease should be used to prevent rusty and hard to turn adjustment screw.Product was not returned for investigation.Resolution was found by tightening the loose screws.There are no capa's related to this issue.This complaint does not identify a deficiency in the product design and therefore a capa is not required.Per qms-004442, complaint histories are reviewed routinely per quality system requirements and any complaint trends are assessed and documented as part of these reviews.Device history review was carried out, and no related faults/issue found, reference to document qa-f-26, rev.4, dco#(b)(4).Faillure confirmed: yes.Investigation result code: neuro sbu|loose component closure rationale: complaint verified, resolved on-site and no further action necessary.

• Brand Name: RETCAM ENVISION, SYSTEM WITH FA
• Common Device Name: RETCAM ENVISION, SYSTEM WITH FA
• Manufacturer (Section D): NATUS MEDICAL INCORPORATED; dba excel-tech ltd. (xltek); 2568 bristol circle; oakville, ontario l6h 5s1, ; CA
• Manufacturer (Section G): NATUS MANUFACTURING LIMITED; ida business park; gort; galway h91pd92, ; EI
• Manufacturer Contact: dba excel-tech ltd; 2568 bristol circle; oakville, ontario l6h 5si,
• MDR Report Key: 16875036
• Report Number: 9612330-2023-00006
• Device Sequence Number: 20678864
• Product Code: HKI
• UDI-Device Identifier: 00382830056335
• UDI-Public: 00382830056335
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K203500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 61-000300
• Device Catalogue Number: 61-000300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 06/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown